OFFICE OF EXTRAMURAL RESEARCH GUIDANCE CONCERNING THE PRODUCTION OF
MONOCLONAL ANTIBODIES IN ANIMALS
Release Date: February 3, 2000
NOTICE: OD-00-019
National Institutes of Health
This Notice provides guidance to Public Health Service (PHS) awardee
institutions and Institutional Animal Care and Use Committees (IACUCs) on
avoiding or minimizing discomfort, distress, and pain to animals in the
production of monoclonal antibodies (mAbs), in accordance with the PHS Policy
on Humane Care and Use of Laboratory Animals.
BACKGROUND
On December 10, 1999, the NIH Director responded to a petition by the American
Anti-Vivisection Society to prohibit the routine use of animals in the
production of mAbs. That response endorses the conclusions and
recommendations of the National Research Council (NRC) report "Monoclonal
Antibody Production. It reiterates the applicable federal animal welfare
standards, affirms existing guidance from the Office for Protection from
Research Risks on policy implementation at the institutional level, and lists
important information resources and NIH-supported core facilities with tissue
culture capabilities.
GUIDANCE TO AWARDEE INSTITUTIONS
Institutions should examine their current IACUC practices regarding the review
and approval of proposals to produce mAbs in animals. The IACUC semiannual
evaluation of the institutional program of animal care and use is an
appropriate mechanism for accomplishing this self-evaluation. Institutions
should use the guidance in the following documents as the basis for
evaluation:
o November 17, 1997 OPRR "Dear Colleague" letter at:
http://grants.nih.gov/grants/olaw/references/dc98-01.htm
o the NRC Monoclonal Antibody Production Report at:
http://grants.nih.gov/grants/policy/antibodies.pdf
o the NIH Director's December 10, 1999 letter at:
http://grants.nih.gov/grants/olaw/references/resp121099.pdf
Institutions currently following the November 1997 OPRR guidance need not make
additional changes in order to be in compliance with the Public Health Service
Policy on Humane Care and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/phspol.htm). The NRC Report and the NIH
Director's response should be used as additional resources to assist IACUCs in
making scientifically and ethically informed assessments of all future
proposals to use the mouse ascites method of mAb production.
INQUIRIES
For questions or further information, contact:
Office of the Director
Office of Extramural Research
Office for Protection from Research Risks
Division of Animal Welfare
6100 Executive Blvd., Suite 3B01
Rockville, Maryland 20892-7507
Telephone: (301) 496-7163
FAX: (301) 402-2803
ng5z@nih.gov